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Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

RTTNews | Před 677 dny

Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

(RTTNews) - Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is currently approved for use in 35 countries.

Based on standard NDA resubmission review timelines, a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date is expected in 30 days. Akebia expects the FDA to set a PDUFA date of six months from the date of submission.

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Značky : AKBA

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Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday that the company expects to resubmit its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis by the end of the third quarter of 2023.

RTTNews | Před 712 dny

New Zealand Jobless Rate Climbs To 5.2% In Q2

New Zealand Jobless Rate Climbs To 5.2% In Q2

The unemployment rate in New Zealand came in at a seasonally adjusted 5.2 percent in the second quarter of 2025, Statistics New Zealand said on Wednesday.

RTTNews | Před 21 minutami

Taiwan Shares May Head South Again On Wednesday

Taiwan Shares May Head South Again On Wednesday

The Taiwan stock market on Tuesday wrote a finish to the two-day losing streak in which it had slipped more than 270 points or 1.2 percent. The Taiwan Stock Exchange now sits just above the 23,660-point plateau although it may see renewed consolidation on Wednesday.

RTTNews | Před 23 minutami

Singapore Stock Market May Spin Its Wheels On Wednesday

Singapore Stock Market May Spin Its Wheels On Wednesday

The Singapore stock market has climbed higher in two straight sessions, gathering more than 50 points or 1.2 percent along the way. The Straits Times Index now sits just beneath the 4,210-point plateau although it may be stuck in neutral on Wednesday.

RTTNews | Před 53 minutami

Malaysia Bourse May Hand Back Tuesday's Gains

Malaysia Bourse May Hand Back Tuesday's Gains

The Malaysia stock market has alternated between positive and negative finishes through the last five trading days since the end of the three-day losing streak in which it had fallen more than 15 points or 1 percent. The Kuala Lumpur Composite Index now sits just beneath the 1,540-point plateau and it's likely to remain rangebound again on Wednesday.

RTTNews | Před 1 h 23 min

Japan Shares May Turn Lower Again On Wednesday

Japan Shares May Turn Lower Again On Wednesday

The Japan stock market on Tuesday wrote a finish to the two-day slide in which it had tumbled almost 780 points or 1.8 percent. The Nikkei 225 now sits just shy of the 40,550-point plateau although it may head south again on Wednesday.

RTTNews | Před 1 h 38 min

South Korea Shares May Be Stuck In Neutral

South Korea Shares May Be Stuck In Neutral

The South Korea stock market has moved higher in back-to-back sessions, advancing almost 80 points or 2.7 percent along the way. The KOSPI now sits just shy of the 3,200-point plateau although the rally may stall on Wednesday.

RTTNews | Před 1 h 53 min

New Zealand Unemployment Data Due On Wednesday

New Zealand Unemployment Data Due On Wednesday

New Zealand will on Wednesday release Q2 figures for unemployment, highlighting a modest day for Asia-Pacific economic activity. The jobless rate is expected to tick up to 5.3 percent from 5.1 percent following a 0.1 percent loss in employment.

RTTNews | Před 2 h 53 min

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